A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Gonal-F Online, Description, Chemistry, Ingredients - Follitropin Alfa
Gonal-F Online, Description, Chemistry, Ingredients - Follitropin Alfa
DESCRIPTION
Gonal-F ® (follitropin alfa for Injection)
For subcutaneous
injection
Gonal-F® (follitropin alfa for Injection) is a human
follicle stimulating
hormone (FSH) preparation
of recombinant DNA
origin, which consists of two non-covalently linked, non-identical
glycoproteins designated as the a- and
b- subunits. The a-
and b- subunits have 92 and 111 amino
acids, respectively, and their primary
and tertiary structure are indistinguishable from those of human
follicle stimulating
hormone. Recombinant FSH
production occurs
in genetically modified Chinese Hamster Ovary (CHO) cells cultured
in bioreactors. Purification by immunochromatography using an antibody
specifically binding FSH
results in a highly purified preparation with a consistent FSH
isoform profile, and
a high specific activity. The biological
activity of follitropin
alfa is determined by measuring the increase in ovary
weight in female
rats. The in vivo biological activity
of follitropin alfa has been calibrated against the second International
Reference Preparation for Human Menopausal Gonadotrophins established
in September 1964 by the Expert Committee on Biological Standards
of the World Health Organization. Gonal-F® contains no
luteinizing hormone (LH) activity. Based on available data derived
from physicochemical tests and bioassays, follitropin alfa and follitropin
beta, another recombinant follicle stimulating hormone
product, are indistinguishable.
Gonal-F® is a sterile,
lyophilized powder intended
for subcutaneous injection after reconstitution
with Sterile Water for Injection, USP. Each ampule of Gonal-F®
contains either 75 IU or 150 IU recombinant
FSH, 30 mg sucrose, 1.11
mg dibasic
sodium phosphate
and 0.45 mg monobasic
sodium phosphate monohydrate. O-phosphoric acid
and/or sodium hydroxide
may be used prior to lyophilization
for pH adjustment. Under
current storage conditions,
Gonal-F® may contain up to 15% of oxidized follitropin alfa.
Therapeutic Class: Infertility
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